BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 1900216 · Received November 10, 2010

    Report

    Report Number
    2210968-2010-01501
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (RECURRENT HERNIA): CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPIGASTRIC HERNIA REPAIR PROCEDURE ON (B)(6) 2009 AND MESH WAS USED. ON (B)(6) 2010, THE PATIENT REPORTED ON THE 12 MONTH FOLLOW-UP THAT THE HERNIA RECURRED IN 2010, AND THE PATIENT WAS TAKING NARCOTIC MEDICATION FOR THIS HERNIA. THE PATIENT UNDERWENT A REPAIR OF THE RECURRENT HERNIA ON (B)(6) 2010. ONE SIDE OF THE MESH FIXATION HAD LOOSENED, AND THE RECURRENCE DEVELOPED AT THE BORDER OF THE PREVIOUS MESH. THE MESH WAS NOT TORN. AT THE LAST CHECK-UP ON (B)(6) 2010, THE PATIENT WAS "PERFECT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPRO MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention